FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Cardiac Assists' Veno-Venous Cannula Gets FDA OK

Aug. 29, 2014

Pittsburgh, Pa., devicemaker CardiacAssist announced Wednesday the launch of its PROTEK DuoTM veno-venous cannula, following receipt of FDA 510(k) clearance. The device is intended for use as a single cannula for draining and reinfusing blood during extracorporeal life-support procedures.

Veno-venous extracorporeal life support is an emerging therapy for the treatment of acute respiratory distress syndrome. It involves infusing oxygen directly into the blood via an oxygenator, or artificial lung.

CardiacAssist said it designed the PROTEK Duo to address two major roadblocks that have prevented VV ECLS therapy from becoming a new standard of care: the difficulty of initiating and maintaining a patient on VV ECLS support and the suboptimal gas exchange rates of currently available devices.

The cannula is inserted via a minimally invasive percutaneous procedure, and patient management is simplified with CardiacAssist’s lightweight and compact TandemHeart pump. The pump is placed directly on the patient, simplifying patient ambulation and allowing freedom of movement not possible with alternative ECLS devices, the company said.

In a clinical trial of 180 adult with acute respiratory distress syndrome, VV ECLS therapy reduced the rate of death and disability by 31 percent compared with mechanical ventilation, the current standard of care, CardiacAssist said. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.